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Boston Scientific Corporation (BSX) Wins Additional EU Approval for Pacemaker



7/30/2012 8:47:32 AM

The Boston Scientific Corp. (NYSE: BSX) implatable pacemaker called Ingenio has received an expanded approval in Europe, which will help the medical device maker expand market share for the product.

Ingenio, which is the first new pacemaker platform launched by Boston Scientific in 10 years, was approved by European regulators in April, and by the U.S. Food and Drug Administration (FDA) in May. This additional approval allows European patients with the pacemaker to undergo MRI scans. Most patients with pacemakers of any kind are not able to have MRIs for other conditions they may have, because the magnets in the MRI machine can interfere with the operation of the pacemaker. Pacemakers are used to treat bradycardia, a condition where the heart beats too slowly.

“The ability to use the Ingenio platform during MRI procedures is a significant advancement to our family of bradycardia devices,” Michael Onuscheck, president of Europe, Middle East and Africa, said in a statement. “This progression in the use of the Ingenio family of pacemakers represents another step in our commitment to expanding our pacing capabilities and improving the lives of patients.”

The Ingenio pacemakers include a technology called RightRate, which is designed to help the heart regulate its rate appropriately during physical activity, and is designed to help patients who feel tired or short of breath after common activities like climbing stairs.

Earlier this year, incoming Boston Scientific CEO Michael Mahoney said increasing the company’s market share in the pacemaker market, which now stands at 15 percent of the $4 billion market, is an important goal for the company.




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